DETAILED ACTION
Applicant's election with traverse of Claims 1-5, 7-21, and 23-32 by Joshua Puvak dated 10/8/25 is acknowledged.
In view of the amendment to Claim 1 and the arguments made in pages 9-10 of the Arguments, the restriction requirement is withdrawn and the Examiner agrees to examine all of claims 1-5, 7-21, 23-34 and 37-41.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-14, 21-22, 25, 27, 29-30, 32-34, 37-38 and 40-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansen et al. (PG Pub. 2019/0282803).
Regarding Claims 1, 40, Hansen discloses an implantable medical device system, comprising:
a stimulation arrangement (see system 100; Fig. 6b) comprising an elongate stimulation assembly (see electrode 126) disposed at a distal end of the stimulation arrangement (see Fig. 6b), wherein the elongate stimulation assembly is configured to be inserted into a cochlea of a recipient (see par. 70); and
an integrated tube sheath (see hollow sheath 150) configured to be permanently disposed around an outer circumference of the stimulation arrangement (see par. 85),
wherein the integrated tube sheath is slideably engaged with the outer circumference of the stimulation arrangement for longitudinal advancement of the elongate stimulation assembly relative to the integrated tube sheath during insertion of the elongate stimulation assembly into the cochlea (see par. 66).
Regarding Claim 2, Hansen discloses the implantable medical device system of claim 1, wherein the integrated tube sheath is configured to structurally support the elongate stimulation assembly during insertion of the elongate stimulation assembly into the cochlea (see par. 86 and 92).
Regarding Claim 3, Hansen discloses wherein at least a distal portion of the integrated tube sheath is configured to be positioned in the cochlea during insertion of the elongate stimulation assembly into the cochlea (see par. 94 and 96), and wherein the distal portion of the integrated tube sheath is configured to be removed from the elongate stimulation assembly following insertion of the elongate stimulation assembly into the cochlea (see par. 93).
Regarding Claim 4, Hansen discloses the stimulation arrangement comprises an elongate transition region (see sheath anchor element 162; Fig. 6a) connected to a proximal end of the elongate stimulation assembly (see Fig. 6b), and wherein, following insertion of the elongate stimulation assembly into the cochlea, an inner surface of the integrated tube sheath is configured to be positioned abutting an outer surface of the elongate transition region to eliminate spacing there between (see par. 82).
Regarding Claim 5, Hansen discloses wherein a portion of the elongate transition region has an outer diameter that is slightly larger than an inner diameter of the integrated tube sheath such, that, when the inner surface of the integrated tube sheath is positioned abutting an outer surface of the elongate transition region, the elongate transition region is configured to apply an outward force on the integrated tube sheath (see par. 82). The examiner considers a screw, barb, clamp or other means would necessarily require some force between the sheath and the transition region.
Regarding Claim 7, Hansen discloses an implant body (see implanted stimulator 460; par. 67) connected to a proximal end of the stimulation arrangement (see Fig. 4a), wherein, following insertion of the elongate stimulation assembly into the cochlea, the integrated tube sheath is configured to be positioned between the elongate stimulation assembly and the implant body (see Fig. 4b).
Regarding Claims 8 and 37, Hansen discloses wherein following insertion of the elongate stimulation assembly into the cochlea, a distal portion of the integrated tube sheath is configured to remain permanently disposed around a proximal region of the elongate stimulation assembly within the cochlea (see par. 94 and 96).
Regarding Claims 9 and 41, Hansen discloses wherein following insertion of the elongate stimulation assembly into the cochlea, the distal portion of the integrated tube sheath is positioned over one or more electrodes of the elongate stimulation assembly, and wherein the distal portion of the integrated tube sheath has an electrically-transparent structure (see sealable tip 725; Fig. 8a) configured to allow stimulation current to flow from the one or more electrodes to the recipient (see par. 95). The examiner considers that in cases where the full length of the electrode does not need to be utilized (see par. 59), the slits 750 of tip 725 would necessarily allow stimulation current to flow to the recipient by the mere size or radius of the electrode being passed through.
Regarding Claim 10, Hansen discloses wherein the distal portion of the integrated tube sheath comprises at least one of a perforated (see slits 750) or mesh-type construction (see Fig. 8c).
Regarding Claim 11, Hansen discloses wherein the distal portion of the integrated tube sheath is at least partially bioresorbable (see gasket 159; Fig. 6) so as to dissolve, in situ, within the cochlea (see par. 97).
Regarding Claim 12, Hansen discloses wherein the integrated tube sheath is configured to fluidically seal an opening in the cochlea through which the elongate stimulation assembly and the integrated tube sheath are inserted and extend through following insertion into the cochlea (see par. 83 and 91).
Regarding Claims 13 and 38, Hansen discloses wherein the integrated tube sheath comprises a slideable sealing member configured to fluidically seal the opening around an outer surface of the integrated tube sheath (see par. 79). The examiner considers a gasket is slideable along the integrated tube sheath (see Fig. 6a) because it depends on the anatomical size of the patient how deep the sheath is placed and where the gasket will create the seal.
Regarding Claim 14, Hansen discloses wherein the slideable sealing member is configured to apply an inward compressive force on the outer surface of the integrated tube sheath to form a fluidic seal between the slideable sealing member and the outer surface of the integrated tube sheath, and wherein the slideable sealing member is configured to be secured to the cochlea around the opening (see par. 79 and Fig. 6a).
Regarding Claim 21, Hansen discloses wherein the integrated tube sheath comprises an annular stopper (sealable tip 725) configured to prevent over-insertion of the integrated tube sheath into the cochlea, and wherein the annular stopper is fluidically seal the opening around an outer surface of the integrated tube sheath (see par. 94).
Regarding Claim 22, Hansen discloses
a stimulator unit (see sealed electronics of 460; par. 67); and
one or more electrodes (see electrode 126) positioned on the distal portion of the integrated tube sheath electrically connected to the stimulator unit (see Fig. 4a).
Regarding Claim 25, Hansen discloses a proximally positioned flexible tube (see stretchable sheath 580) having a distal end connected to a proximal section of the integrated tube sheath and a proximal end connected to a proximal section of the stimulation arrangement, wherein the flexible tube is configured to extend a certain distance relative to the elongate stimulation assembly while maintaining a continuous fluidic barrier (see Fig. 5b and par. 81).
Regarding Claim 27, Hansen discloses wherein the flexible tube comprises a helical surface profile (see helical shape as sheath 580 wraps around rotor 520; Fig. 5b).
Regarding Claim 29, Hansen discloses wherein the integrated tube sheath is an actuated sheath configured to automatically partially or fully insert the elongate stimulation assembly into the cochlea (see motor 122; par. 70 and 89).
Regarding Claim 30, Hansen discloses wherein the stimulation arrangement includes an elongate embedded stiffener (see guide wire 630; par. 87) disposed proximal to the elongate stimulation assembly (see Fig. 6b).
Regarding Claim 32, Hansen discloses wherein the integrated tube sheath comprises a fixation feature (see material scaffold; par. 97) for securing the integrated tube sheath to the recipient.
Regarding Claim 33, see rejection of similarly worded Claim 1 above. Hansen further discloses forming a surgical opening in a body of a recipient of an implantable medical device system (see par. 94); inserting a stimulation arrangement through the surgical opening (see par. 59), positioning a distal end of the stimulation arrangement and a distal end of the integrated tube sheath into a cavity within the body of the recipient (see par. 82); sliding the elongate stimulation assembly relative to the integrated tube sheath to insert the elongate stimulation assembly into the cavity (see par. 68); and following insertion of the elongate stimulation assembly into the cavity, closing the surgical opening in the body with the elongate stimulation assembly and the integrated tube sheath within the body of the recipient (see par. 96-97).
Regarding Claim 34, see rejection of similarly worded Claims 3 and 4 above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 15-18, 23, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (PG Pub. 2019/0282803).
Regarding Claims 15 and 39, Hansen discloses wherein a sealing member (see internal valves 710, 720, 730) is configured to fill an interior of the integrated tube sheath between an inner surface of the integrated tube sheath and the outer surface of the elongate stimulation assembly at the opening and to apply an inward compressive force on the outer surface of the elongate stimulation assembly to form a fluidic seal between the integrated tube sheath and the elongate stimulation assembly to fluidically seal the interior of the integrated tube sheath (see par. 79 and Fig. 7a-7b). Hansen does not disclose these valves are slideable. It would have been obvious to one of ordinary skill in the art at the time of the invention make the valves slideable since it has been held that the provision of adjustability, where needed, involves only routine skill in the art (In re Stevens, 101 USPQ 284 (CCPA 1954)).
Regarding Claim 16, Hansen does not disclose that the sealing member is fixed. It would have been obvious to one of ordinary skill in the art at the time of the invention to include a fixed sealing member comprising at least one annular member extending about a circumference of an outer surface of the integrated tube sheath, wherein the at least one annular member is configured to be secured to the cochlea adjacent to the opening to fluidically seal the opening through which the integrated tube sheath extends since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (In re Larson, 340 F.2d 965,968,144 USPQ 347, 349 (CCPA 1965)).
Regarding Claim 17, Hansen discloses further comprising at least one inner annular member (see internal valves 710, 720, 730; Fig. 7a and 7b) extending about a circumference of an inner surface of the integrated tube sheath, wherein the at least one inner annular member is configured for an interference fit with an outer surface of the elongate stimulation assembly to fluidically seal an interior of the integrated tube sheath (see par. 91).
Regarding Claim 18, Hansen does not disclose that the annular members extend about a circumference of an outer surface of the elongate stimulation assembly. It would have been obvious to one of ordinary skill in the art at the time of the invention to place the annular members on the elongate stimulation assembly instead of on the inner surface of the integrated tube sheath since it has been held that rearranging parts of an invention involves only routine skill in the art (In re Japikse, 86 USPQ 70) and the result would still be a fluidic seal between the sheath and the stimulation assembly.
Regarding Claim 23, Hansen does not disclose the annular stopper is configured to be secured to the cochlea for a fluidic seal because ring gasket 159 does that job. It would have been obvious to one of ordinary skill in the art at the time of the invention to substitute an annular stopper for the ring gasket 159 since they perform substantially the same function of providing a fluidic seal where the sheath meets the opening of the cochleostomy (see par. 97).
Claim(s) 19-20 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen as applied to claims 1 and 12 above, and further in view of Silvestrini et al. (US Patent 8672870).
Regarding Claims 19 and 20, Hansen does not disclose a hydrogel as a fluidic seal. Silvestrini discloses an implant that uses hydrogel to fluidically seal openings (see col. 33, lines 26-47). It would have been obvious to one of ordinary skill in the art at the time of the invention to place hydrogel outside or inside of the sheath to use a hydrogel to fluidically seal any openings because of its expansive properties (see col. 33, lines 11-25).
Regarding Claim 31, Hansen does not explicitly disclose a handle but does disclose a manual override mechanism to manually insert the electrode (see par. 102). Silvestrini discloses wherein the integrated tube sheath comprises a handle (see handle 515) disposed at a proximal end of the integrated tube sheath. It would have been obvious to one of ordinary skill in the art at the time of the invention to include a handle for the manual override because Silvestrini teaches it controls the implant placement (see col. 11, lines 40-52).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen as applied to claim 12 above, and further in view of Poirier et al. (US Patent 4886502).
Regarding Claim 26, Hansen does not disclose flexible tube 580 comprises a concertina-shaped tube with one or more waves. Poirier discloses a flexible tube comprises a concertina-shaped tube with one or more waves (see section 81; Fig. 7). It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize this shape because Poirier teaches it acts as a shock absorber to relieve any stress from movement of the external device (see col. 3, lines 28-40).
Allowable Subject Matter
Claim 24 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art of record does not show a slideable plug at the proximal end of the integrated tube sheath with a corresponding plug port that would be obvious to combine with Hansen because Hansen teaches sheath anchor element 162 for providing the fluidic barrier.
Conclusion
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/N.P/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792